Trial Review

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Preliminary Efficacy of Implementing a Program of Exercise Medicine for Men on Prostate Cancer Active Surveillance - a Pilot Study

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Scientific title

Preliminary Efficacy of Implementing a Program of Exercise Medicine for Men on Prostate Cancer Active Surveillance - a Pilot Study

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Secondary ID [1]2875640

None

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Universal Trial Number (UTN)

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Prostate cancer2963450

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Condition category

Condition code

Cancer29662129662100

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Prostate

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Intervention group: Supervised resistance and aerobic exercise performed over 3 sessions per week (approx. 60 min per session) for 6 months. Resistance exercise involves 6-8 exercises that target the major upper and lower body muscle groups. Intensity is manipulated from 6-12 repetition maximum using 1-4 sets per exercise. The aerobic exercise component includes 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. The exercise sessions are conducted in small groups and under direct supervision by an accredited exercise physiologist. Participants are encouraged to undertake additional aerobic exercise outside the clinic sessions with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Exercise adherence is assessed by register of attendance at the exercise sessions and exercise diary for home exercises.

Usual care group: Unsupervised walking program and an educational booklet outlining the current national aerobic exercise recommendations for cancer survivors along with a log-book to record the physical activity. Patients are encouraged to achieving a total of at least 150 minutes of aerobic exercise per week by month 6.

1) Be within 1 year of diagnosis of prostate cancer (clinical state as T1C and T2, Gleason score smaller than or equal to 6 (or as determined by treating clinician) and under 3 biopsy cores invaded with prostate cancer, PSA < 10ng/ml and PSA density < .2ng/ml) and undergoing active surveillance2) Have physician consent3) Willing to be randomised4) Able to read and understand English

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Minimum age

18Years

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Maximum age

No limit

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Gender

Males

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Can healthy volunteers participate?

No

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Key exclusion criteria

1) Received former therapy for prostate cancer2) Not fit for curative treatment3) Already performing regular exercise defined as undertaking structured resistance and aerobic training two or more times per week within the past 3 months4) Any acute illness, musculoskeletal, cardiovascular or neurological disorder that could inhibit a participant's ability to participate in the exercise program or put them at risk of injury or illness.

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Randomised controlled trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

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Masking / blinding

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Who is / are masked / blinded?

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Intervention assignment

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Other design features

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Phase

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Type of endpoint(s)

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Statistical methods / analysis

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Recruitment

Recruitment status

Recruiting

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Date of first participant enrolment

Anticipated

1/07/2015

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Actual

7/07/2015

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

30

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Accrual to date

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Final

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Recruitment in Australia

Recruitment state(s)

WA

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Funding & Sponsors

Funding source category [1]2921320

University

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Name [1]2921320

Edith Cowan University

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Address [1]2921320

270 Joondalup DriveJoondalup WA 6027

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Country [1]2921320

Australia

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Primary sponsor type

University

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Name

Edith Cowan University Exercise Medicine Research Institute

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Address

270 Joondalup DriveJoondalup WA 6027

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Country

Australia

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Secondary sponsor category [1]2908100

None

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Name [1]2908100

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Address [1]2908100

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Country [1]2908100

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]2936120

Human Research Ethics Committee

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Ethics committee address [1]2936120

Edith Cowan University270 Joondalup DriveJoondalup WA 6027

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Ethics committee country [1]2936120

Australia

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Date submitted for ethics approval [1]2936120

01/04/2015

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Approval date [1]2936120

05/05/2015

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Ethics approval number [1]2936120

12550

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Summary

Brief summary

The primary purpose of this study is to determine the feasibility and efficacy of an exercise program to ameliorate the primary physical and mental health problems faced by men on prostate cancer active surveillance and to explore potential mechanisms underlying the influence of phsical exercise on markers of disease progression.

Who is it for?You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer in the previous year, currently undergoing active surveillance.

Study detailsParticipants will be randomly allocated (by chance) to receive either the exercise program or usual care. Participants in the exercise program group will receive supervised resistance and aerobic exercise sessions, each lasting approximately one hour, three times per week for six months. These participants will also be encouraged to complete additional aerobic exercise at home to create a total of 150 minutes of moderate aerobic exercise per week. Participants allocated to receive usual care will be encouraged to complete a walking program and will be given an information booklet detailing the current national aerobic exercise recommendations for cancer survivors along with a log-book to record their physical activity. The aim will be to complete a total of 150 minutes of aerobic exercise per week by month 6.

Patient outcomes will then be assessed through blood samples, fitness tests and questionnaires at 3 months and 6 months.

It is hoped that the findings of this trial will provide information regarding the feasibility of implementing an exercise intervention for prostate cancer patients on active surveillance, as well as the efficacy of such a program on mental and physical health outcomes, as well as on disease progression.